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What do you know about the Penn State trial of low-dose naltrexone for Crohn's? I've heard 67 percent disease remission, and now on to a large trial funded by the NIH. This is exciting news as LDN is available now as an off-label oral prescription and has no harmful side effects.

At Digestive Diseases Week, a conference held in Los Angeles in May last year, investigators from Penn State College of Medicine presented two projects related to low-dose naltrexone in inflammatory bowel disease. Naltrexone is an opioid antagonist that is currently available to treat alcohol and drug addiction. It also may reduce intestinal inflammation and promote repair of ulcerated intestinal lining.

The first study showed that mice given naltrexone had less inflammation than mice given saline when both groups of mice were previously given a chemical that induces inflammation. In the second study, 17 Crohn’s disease patients were given naltrexone in an open-label, non-placebo controlled fashion. About 89 percent responded with at least a 70-point drop in the Crohn’s disease activity index and 67 percent achieved remission. Some patients had healing of either mucosal ulcerations or fistulas. The most common adverse effect reported was sleep disturbance in 41 percent of patients.

Uncontrolled pilot studies such as this small trial must be interpreted with caution. The placebo response rate in Crohn’s disease trials is usually about 30 percent, but might be 50 percent or higher. This promising therapy appears to be safe, but cannot be deemed effective until a randomized placebo-controlled trial is completed.

Last Updated: 6/4/2007

Crohn's disease expert Dr. Bret Lashner is the director of the Center for Inflammatory Bowel Disease at the Cleveland Clinic Foundation.

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